Clopidogrel ratiopharm

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

On 23 September 2009, the European Commission issued a marketing authorisation valid throughout the European Union for the generic medicinal product Clopidogrel ratiopharm, which had been approved for: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

• Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. 

The marketing authorisation holder (MAH) responsible for Clopidogrel ratiopharm was Archie Samuel s.r.o.. 

On 25 October 2013, the European Commission issued a decision to withdraw the marketing authorisation for Clopidogrel ratiopharm, following its receipt of a letter dated 10 September 2013 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. 

Clopidogrel ratiopharm was not marketed in any European country. Pursuant to this decision, the European public assessment report for Clopidogrel ratiopharm is updated to reflect that the marketing authorisation is no longer valid.

Clopidogrel ratiopharm : EPAR - Summary for the public

Product information

Clopidogrel ratiopharm : EPAR - Product Information

Clopidogrel ratiopharm : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel ratiopharm
• Active substance:
  clopidogrel
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  • Peripheral Vascular Diseases
  • Stroke
  • Myocardial Infarction
• Anatomical therapeutic chemical (ATC) code:
  B01AC04

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

• patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

For further information please refer to section 5.1.

Authorisation details

• EMA product number:
  EMEA/H/C/001173
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Archie Samuel s.r.o.

  Slunná 16 ; 61700 Brno ; Czech Republic

• Marketing authorisation issued:
  23/09/2009
• Withdrawal of marketing authorisation:
  25/10/2013
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Clopidogrel ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation

Clopidogrel ratiopharm-H-C-1173-A20-08 : EPAR - Assessment Report - Article 20

Adopted

Initial marketing authorisation documents

Clopidogrel ratiopharm : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Clopidogrel ratiopharm

Reference Number: EMEA/CHMP/375222/2009